The Role of Angiogenesis-related Pathways in the Development of Port Wine Stains

NCT03948997 | Completed DMC

• 1 other identifier: XijingH-PF-20150902
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Port wine stain (PWS) is a congenital, progressive vascular malformation of human skin involving the superficial vascular plexus that occurs in estimated 3-5 children per 1,000 live births. In childhood, PWS are flat red macules, but lesions tend to darken progressively to purple and, by middle age, often become raised as a result of the development of vascular nodules. Because most malformations occur on the face, PWS is a clinically significant problem in the majority of patients.
2. 2.The late-stage cobblestoning appearance of PWS subjects is comprised by not only pronounced vascular ectasia with proliferation of thin and/or thick-walled vessels and their stroma, but also numerous epithelial, neural and mesenchymal hamartomatous abnormalities. Despite these histologic observations, the specific mechanisms involved in PWS nodular formation remains unclear.
3. 3.In one nodular PWS subject, we found that phosphatidylinositol 3-kinases (PI3K)/protein kinase B (AKT) and phosphoinositide phospholipase C g subunit (PLC-g) were activated in both hypertrophic areas and nodules within the lesion. These observations led us to hypothesize that the PI3K pathway may play an important role in nodular formation.

Conditions

Port Wine Stain

Keywords

port wine stain, PI3K, vascular malformation,PDL

Outcome Measures

Primary Outcomes (1)

• Exon mutation sequences and mutation frequencies

  In patients with nodular port wine stains, the exon mutation sequence and mutation frequency were compared between normal skin tissue (or blood), erythema and nodular tissue of the same patient.

  Baseline (before treatment)

Secondary Outcomes (1)

• Changes in the levels of cytokines in serum and skin tissues

  baseline (before treatment) and 1, 3, 7 days after treatment

Study Arms (2)

Treatment group

EXPERIMENTAL

Patients with port wine stains receive PDL (1.5-10ms, 11-12.5J/cm2) with a treatment range of approximately 10\*10cm2

Radiation: Pulsed dye laser (PDL)

No treatment group

NO INTERVENTION

Patients with port wine stains have not been treated with PDL treatment

Interventions

Pulsed dye laser (PDL) RADIATION

Pulsed dye laser (PDL, 595nm) is effective for vasodilatory diseases, especially for the superficial to middle layers of the dermis

Treatment group

Eligibility Criteria

• Age: 1 Month - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 1 month - 70 years old, male or female;
• The patient and the family of the child agreed to participate in the experiment and signed an informed consent form;
• Clinical diagnosis of refractory port wine stains with thickened nodular or PDL resistance; .There is no bleeding, ulceration, infection, etc. affecting the visual field of laser surgery operation.

You may not qualify if:

• Patients with severe infectious diseases;
• Heart disease patients;
• Epilepsy patient;
• Pregnant patient;
• Researchers believe that patients who are not suitable for this experiment

Sponsors & Collaborators

• xjpfW: lead
• Air Force General Hospital of the PLA: collaborator
• First Hospital of China Medical University: collaborator
• Chinese Academy of Medical Sciences: collaborator

MeSH Terms

Conditions

Port-Wine Stain; Hereditary Sensory and Autonomic Neuropathies

Interventions

Lasers, Dye

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Gang Wang, Prof

  Dermatology Derpartment of Xijing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Dermatology

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 14, 2019
• Study Start: October 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share